MICONAZOLE 7- miconazole nitrate suppository 
H2-Pharma, LLC

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Miconazole 7

Drug Facts

Active ingredient (in each vaginal suppository)

Miconazole nitrate, USP 100 mg

Purpose

Vaginal antifungal

Use

Warnings

For vaginal use only

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor.

Ask a doctor before use if you have

  • vaginal itching and discomfort for the first time
  • vaginal yeast infections often (such as once a month or 3 in 6 months). You may have a more serious condition. You could be pregnant or have a medical condition, such as diabetes or a weakened immune system.
  • lower abdominal, back, or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge
  • been exposed to the human immunodeficiency virus (HIV) that causes AIDS

Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur.

When using this product

  • do not use tampons, douches, spermicides or other vaginal products
  • do not use condoms or diaphragms. They may be damaged by this product and not prevent pregnancy or sexually transmitted diseases (STDs).
  • do not have vaginal intercourse (sex)
  • mild increase in vaginal burning, itching or irritation may occur

Stop use and ask a doctor if

  • side effects occur
  • symptoms do not get better after 3 days
  • symptoms last more than 7 days
  • you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Other information

Inactive ingredient

hydrogenated vegetable oil

Questions?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Distributed by: H2-Pharma, LLC
Montgomery, AL 36117

PRINCIPAL DISPLAY PANEL - 100 mg Suppository Box

NDC 61269-736-07
*Compare to the active ingredient in
Monistat® 7

Miconazole 7

Miconazole nitrate
Vaginal suppositories, USP 100 mg
Vaginal antifungal

Cures most vaginal yeast infections

7 vaginal suppositories with 1 reusable plastic applicator

H2 pharma

PRINCIPAL DISPLAY PANEL - 100 mg Suppository Box
MICONAZOLE 7 
miconazole nitrate suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61269-736
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) Miconazole Nitrate100 mg
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
PALM KERNEL OIL (UNII: B0S90M0233)  
Product Characteristics
ColorWHITEScore    
ShapeOVALSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61269-736-077 in 1 BOX; Type 0: Not a Combination Product05/24/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07350705/24/2021
Labeler - H2-Pharma, LLC (028473634)

Revised: 5/2021
Document Id: 081fb777-9c72-4165-a11e-91cd6dd04000
Set id: a003ad26-271f-46af-8b9a-8b7fb80b93ff
Version: 1
Effective Time: 20210524
 
H2-Pharma, LLC